AEGEA Medical Completes Enrollment in the PACE II Clinical Trial
Study is assessing uterine cavity access and projected intervention feasibility three to four years post endometrial vapor ablation for heavy menstrual bleeding
MENLO PARK, Calif. – (BUSINESS WIRE)–AEGEA Medical announced it has completed enrollment in the Post-Ablation Cavity Evaluation (PACE II) clinical study in women who previously underwent endometrial ablation as part of a pivotal trial of AEGEA’s Adaptive Vapor Ablation technology. The multi-center observational study enrolled 50 women at seven sites across the U.S. The trial was designed to assess uterine cavity access as well as the projected feasibility of diagnostic and therapeutic interventions three to four years following treatment. PACE II enrollment commenced in the fall of 2018, with data to be released throughout 2019. The study’s National Principal Investigator is Alan Johns, MD, Medical Director, Baylor Research Institute, Fort Worth.
“If uterine cavity access after an ablation procedure is possible, it would allow more diagnostic and therapeutic options for my patients,” said study Investigator Cindy Basinski, MD, Newburgh, Ind. “Positive data from the PACE II study could position vapor ablation technology as a compelling new option in the field of endometrial ablation.”
Endometrial ablation is a safe, effective and fast-growing procedure for the treatment of heavy menstrual bleeding (menorrhagia), with the number of U.S. cases estimated to have increased from 430,000 in 2014 to 490,000 in 2017 alone.1 As the number of procedures continues to rise per year, studies have shown that scar tissue and re-access to the cavity can be challenging post therapy, limiting the ability to search for suspected cancer via biopsy, and ruling out the use of IUDs for therapeutic intervention.2,3,4,5 In these scenarios, the lack of post-procedure uterine cavity access often leaves women with hysterectomy as the only viable option.
“We are encouraged by the active enrollment in PACE II, as it indicates a strong interest in the topic of post-ablation uterine cavity access among both physicians and patients,” said Maria Sainz, president and CEO of AEGEA Medical. “This is such an important consideration related to the treatment of heavy menstrual bleeding, and AEGEA is proud to have taken the lead on a multi-center, controlled study to deepen the understanding of vapor ablation and cavity access.”
About Heavy Menstrual Bleeding (Menorrhagia)
Many women experience heavy menstrual bleeding at some point in their lives. Nearly 1 in 5 women between the ages of 30 and 50 experience abnormally heavy or prolonged menstrual bleeding. Healthcare professionals call this condition “abnormal uterine bleeding (AUB)” or “menorrhagia”. The increase in quantity and duration can negatively impact every day routine activities such as work and family care. It can also make it difficult to exercise and to be socially or sexually active.
Important Safety Information
The AEGEA Vapor System is indicated for premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. As with all surgical procedures, there are risks and considerations associated with the use of the AEGEA Vapor System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.
AEGEA Medical is pioneering the application of its Adaptive Vapor Ablation technology to deliver therapies that provide high quality patient outcomes to a wider range of patients. AEGEA’s FDA approved water vapor technology enables the delivery of a safe and effective endometrial ablation for the treatment of menorrhagia in a simple, office-based procedure that takes only minutes. With a vision to expand safe and effective treatment options to more patients, and provide physicians with the confidence and convenience necessary to perform office-based procedures, AEGEA is inspiring new approaches to women’s healthcare. Founded in 2008, AEGEA Medical is located in Menlo Park, Calif. For more information, visit AEGEAmedical.com.
- Wortman M, Cholkeri A, McCausland A, McCausland V. Late Onset Endometrial Ablation Failure: Etiology, Treatment and Prevention. J Minim Invasiv Gynecol 2015; 22 p.323-31.
- Ahonkallio SJ, Liakka AK, Martikainen HK, Santala MJ. Feasibility of Endometrial Assessment After Thermal Ablation. Eur J Obstet Gynecol Reprod Biol 2009 Nov; 147(1) p 69-71.
- Leung PL, Tam WH, Yuen PM. Hysteroscopic Appearance of the Endometrial Cavity Following Thermal Balloon Endometrial Ablation. Fert Steril 2003; 79(5) p 1226-8.
- Luo X, Lim CED, Li L, Wong WSF. Hysteroscopic Appearance of the Endometrial Cavity After Microwave Endometrial Ablation. J Minim Invasiv Gynecol 2010 17 p. 30-6.
- Bruno R, McLellan R, Birdsall M, et al. Hysteroscopic Findings Following Cryoablation – 75 Cases. JAAGL 2003; Suppl 10(3) p S17.
AEGEA Medical, AEGEA Vapor System, SmartSeal, and IntegrityPro, and associated logos, are trademarks and/or registered trademarks of AEGEA Medical.
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Important Safety Information:
The Mara Water Vapor Ablation System is indicated to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Pregnancy following the Mara procedure can be dangerous. The Mara procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.